EVAR, DREAM, ACE and OVER trial updates

At the recent LINC meeting, Leipzig, Germany, Louise Brown presented an overview of the results from several endovascular aneurysm repair (EVAR) versus open repair trials in fit patients anatomically suitable EVAR. She presented the results from the EVAR 1 (UK), DREAM (Netherlands), ACE (France) and OVER (US) trials.

In regards to recruitment two of the trials, OVER and EVAR 1 recruited the target number (EVAR 1 target number – 900, final number– 1,252; OVER target number –872, final number – 881), whereas the DREAM and ACE trials did not achieve their recruitment targets (DREAM target number – 400, final number –351; ACE target number – 600, final number – 306).

Brown reported that there were noted patient differences between the trials. For example in the EVAR 1 trial the mean age was 74 years, whereas in the DREAM and OVER trial the mean age was 70 years. In the EVAR 1 and DREAM trial 90% of patients were male and in the OVER trial 99% were male. The mean AAA size in the EVAR 1 trial was 6.5cm, but was lower in the DREAM (6.1cm) and OVER (5.7cm) trials. There were also differences in aspirin use between the trials (DREAM [40%], EVAR [53%] and OVER [59%]. Finally, there were also differences between the trials in the type of stent graft device utilised (EVAR, DREAM: Zenith/Talent/Gore- OVER: Zenith/Gore/AneuRx).

“However, despite these differences, the results show a clear consensus on operative mortality,” said Brown. Other results across the trials showed a similar two year survival rate of approximately 85–90%, although the OVER trials showed a lower AAA-related mortality. In addition, there were no differences for erectile dysfunction, health related quality of life scores and the trials reported similar overall costs. However, complications and re-interventions differences were difficult to ascertain due to differing reporting protocols and cost effectiveness decisions vary between the trials.

Interestingly, there were differences between the trials in regards to all cause mortality catch up (the point at which the all-cause mortality rate between both EVAR and open repair groups was the same).

For example, in the EVAR 1 trial the catch up was recorded at two years after randomisation (Lancet 2005;365: 2179-86); in the DRAM trial the catch up was recorded at 12 months (NEJM 2005; 352: 2398-405); however in the OVER trial no catch has been recorded at two years (JAMA 2009; 302: 1535-1542). Moreover, Schermerhorn et al (NEJM 2008; 358: 464-74) reporting US Medicare data have shown all-cause mortality catch-up (from 45,660 patients) at three years.

Additional insights from these trials will be available in the coming months with the long-term results from the EVAR 1 and DREAM trials reporting later in 2010. The early-mid term results from the ACE trials are to be published imminently, with the long-term results from ACE and OVER to be published in 2012.

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